PMID- 36069160 OWN - NLM STAT- MEDLINE DCOM- 20221215 LR - 20230413 IS - 1096-9101 (Electronic) IS - 0196-8092 (Print) IS - 0196-8092 (Linking) VI - 54 IP - 10 DP - 2022 Dec TI - Long-term improvement in the appearance of hypertrophic scars following a single treatment with acoustic subcision-A single center proof-of-concept study. PG - 1251-1260 LID - 10.1002/lsm.23596 [doi] AB - INTRODUCTION AND OBJECTIVES: Fibrosis, including hypertrophic scar formation, is a pathological condition characterized by excessive production and accumulation of collagen, and loss of tissue architecture, in response to wound healing. Alterations in the extracellular matrix (ECM) biomechanical properties may be important in modulating myofibroblasts and fibrosis formation. The acoustic subcision device uses rapid acoustic pulse technology to noninvasively improve the appearance of hypertrophic scars through both microdisruption of scar tissue matrix and downregulation of fibrotic fibroblasts leading to scar remodeling. The objective of this single-site proof-of-concept IRB-approved human clinical study was to evaluate the efficacy of acoustic subcision device for the improvement in the appearance of hypertrophic scars. METHOD: Eleven hypertrophic scars in 10 participants were treated with a single 6-minute acoustic subcision application without anesthesia. Posttreatment adverse events (AEs) and tolerability were recorded. At 12 and 89 weeks posttreatment, scar heights and volumes were measured, and participant satisfaction questionnaires were completed. Finally, at the last visit the scar appearance was assessed by the Principal Investigator (PI) using the Mecott Modified Scar Scale (MMSS). RESULTS: Immediately following the acoustic subcision treatment, only mild, moderate erythema or pinpoint bleeding were noted. The treatment sessions were considered tolerable by all participants with an average pain score of 2.2 (on a 0-10 pain score with 10 being the worse possible pain). The 12- and 89-week assessments demonstrated mean height reductions of 46.3% and 56.8%, respectively from baseline. The differences in scar height were statistically significant (p < 0.01). The 12- and 89-week assessments demonstrated a mean volume reduction of 63.2% and 58.1% respectively from baseline. The differences in the scar volume were statistically significant (p < 0.001). The PI graded an average improvement of 33.7% in scar appearance using the MMSS, a statistically significant change (p < 0.001). Finally, >90% of participants reported satisfaction with the improvement in their scar. CONCLUSION: This proof-of-concept study showed that a single noninvasive acoustic subcision treatment session can safely provide statistically significant improvement in the appearance of hypertrophic scars with minimal treatment pain and meaningful participant satisfaction. More work is needed on a larger number of scars to verify this finding. Further improvement in appearance is expected with multiple acoustic subcision treatments and/or treatments in combination with currently available options. Additional trials to verify this are planned. CI - (c) 2022 Soliton, Inc. Lasers in Surgery and Medicine published by Wiley Periodicals LLC. FAU - LaTowsky, Brenda AU - LaTowsky B AD - Clear Dermatology and Aesthetic Center, North Scottsdale, Arizona, USA. FAU - Robertson, David W AU - Robertson DW AUID- ORCID: 0000-0003-0149-0868 AD - Asyst Medical, LLC, Ogunquit, Maine, USA. FAU - Capelli, Christopher C AU - Capelli CC AUID- ORCID: 0000-0003-3456-8895 AD - Soliton, Inc., Houston, Texas, USA. LA - eng PT - Case Reports PT - Research Support, Non-U.S. Gov't DEP - 20220907 PL - United States TA - Lasers Surg Med JT - Lasers in surgery and medicine JID - 8007168 SB - IM MH - Humans MH - *Cicatrix, Hypertrophic/etiology/pathology MH - Cicatrix/therapy MH - *Acne Vulgaris MH - Wound Healing MH - Pain MH - Acoustics MH - Treatment Outcome PMC - PMC10087232 OTO - NOTNLM OT - acoustic subcision OT - fibrosis OT - hypertrophic scar OT - improvement in appearance OT - noninvasive OT - rapid acoustic pulse EDAT- 2022/09/08 06:00 MHDA- 2022/12/16 06:00 PMCR- 2023/04/11 CRDT- 2022/09/07 04:42 PHST- 2022/07/24 00:00 [revised] PHST- 2021/11/30 00:00 [received] PHST- 2022/08/21 00:00 [accepted] PHST- 2022/09/08 06:00 [pubmed] PHST- 2022/12/16 06:00 [medline] PHST- 2022/09/07 04:42 [entrez] PHST- 2023/04/11 00:00 [pmc-release] AID - LSM23596 [pii] AID - 10.1002/lsm.23596 [doi] PST - ppublish SO - Lasers Surg Med. 2022 Dec;54(10):1251-1260. doi: 10.1002/lsm.23596. Epub 2022 Sep 7.